Wednesday, August 15, 2018

Very Brief Blog: Legislation Would Cover Know-Error DNA Biopsy Provenance Test; Not Covered by MACs

In a brief tidbit, the MolDx program does not cover the Know Error Test, a DNA test that confirms the provenance (origin) of biopsy specimens.   One focus of test use has been in prostate cancer biopsies.    See the MolDx noncoverage article A55274 here.  For a 2014 article on the product's "Medicare reimbursement snags" see here.

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I ran across a November 2017 article on MedScape (email registration may be required) that legislation to cover the test had been proposed.   For the article, here.  To read the full text of the bill, H.R. 2557, here.

The bill would add this language to SSA 1862(a)(1) at new entry "Q":
^  " in the case of a DNA Specimen Provenance Assay clinical diagnostic laboratory test (DSPA test) furnished on or after the date specified in section 1834A(j)(4), unless the DSPA test is furnished to an individual enrolled under part B who has had a prostate cancer biopsy the results of which are positive, the DSPA test is furnished with respect to such biopsy, and the DSPA test is ordered by the physician who furnished the prostate cancer biopsy that obtained the specimen tested;”
Payment from the bill's (possible) passage, until the year 2028, would be fixed at $200.


The 2014 article ("snags") cites a $30M investment from Nantworks; see 2012 press release here.